FDA 510(k) Application Details - K232344

Device Classification Name	More FDA Info for this Device
510(K) Number	K232344
Device Name	Allia IGS 3, Allia IGS 5, Allia IGS 7, Allia IGS 7 OR
Applicant	GE Medical Systems SCS 283 Rue De La Miniere Buc 78530 FR Other 510(k) Applications for this Company
Contact	Hubert Welsch Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OWB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/04/2023
Decision Date	10/11/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review